Demodex BlepharitisNCT04780165
Efficacy and Tolerability of Blephademodex Wipes
A study testing Blephademodex in people with Demodex Blepharitis, run by Laboratoires Thea at 1 site in Germany.
Trial summary
Primary Objective To evaluate efficacy of Blephademodex eyelid hygiene wipe treatment with a subsequent maintenance period with Blephaclean lid cleansing wipes in Demodex blepharitis, as assessed by the change in ocular symptoms by a Global Discomfort Scale (GDS). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Demodex Blepharitis
- What is being tested?
- Blephademodex
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 11 Sep 2019to 14 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient > 18 years old, all genders
- Able to read, to write and to fully understand German language
- Good general health as determined by the investigator by medical history and physical appearance
- Provision of written informed consent prior to inclusion
- Moderate to Severe Blepharitis - grade ≥ 2 (Efron Scale)
- Global discomfort score (GDS) ≥ 4
- Proof of demodex infestation by at least ONE of the following:Demodex visible after lash manipulation;Cylindrical dandruff along the lash line; Lid margin itching; Madarosis
Who cannot join
- History of ocular trauma, ocular infection or intra-ocular inflammation within the 3 months before screening visit
- History of ocular refractive surgery and any other ocular surgeries within 3 months before screening visit
- History of ocular allergy or ocular herpes within the 3 months before screening visit
- History of inflammatory corneal ulcer within the 6 months before screening visit
- Sjogren syndrome or any other rheumatologic disease related dry eye
- Concurrent treatment with other eye drops (anti-infectives, steroids, prostaglandins (but artificial tears are ok).
- Specific Exclusion Criteria for Women:Patient who verbally confirms pregnancy or lactation; Childbearing potential woman who is not using a reliable method of contraception (oral contraceptive, intra-uterine device, subcutaneous contraceptive implant, vaginal ring, patch or condom) and is not surgically sterilised
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Open Label, Multicenter Trial to Investigate the Efficacy and Tolerability of Blephademodex Wipes in Patients With Demodex Blepharitis
Primary Objective
- To evaluate efficacy of Blephademodex eyelid hygiene wipe treatment with a subsequent maintenance period with Blephaclean lid cleansing wipes in Demodex blepharitis, as assessed by the change in ocular symptoms by a Global Discomfort Scale (GDS).
Read more
Secondary Objectives
- To evaluate the efficacy of Blephademodex eyelid hygiene wipe treatment in Demodex blepharitis as assessed by the change alone and in combination with a subsequent maintenance period of treatment with Blephaclean eyelid cleansing wipes ocular symptoms by: adapted TOSS; SANDE; specific blepharitis symptoms; Demodex count; ocular surface redness (Efron scale); lid margin redness/swelling (Efron / custom scale); Dandruff coverage at bases of eyelashes; ocular surface staining (Oxford scale; corneal only)
- To evaluate subject and physician satisfaction with Blephademodex eyelid hygiene wipes
- To evaluate ease of use for Blephademodex eyelid hygiene wipes
- Adverse events are documented and analyzed.
- Conditions
- Demodex Blepharitis
- Being tested
- Blephademodex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlephademodexDevice
Also called Blephaclean
During the first 28 days of the trial, subjects will use one Blephademodex® eyelid hygiene wipe every evening per eye to clean the eyelids of both their eyes. At the start of the second period the Investigator will assess based on the GDS if the condition is resolved and manage accordingly: subjects will either continue with this regime if GDS is unchanged (further treatment phase) or revert to Blephaclean wipes every evening instead (maintenance phase), again to clean the eyelids of both their eyes.
| Study group | Role | What they receive |
|---|---|---|
| Single-arm | Experimental | Not described Receives: Device: Blephademodex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Discomfort Score
Change from Baseline at Day 28 The Global (overall) discomfort score (GDS) consists of a single question, which can be answered by the subject by choosing a value between 0 (no discomfort) and 10 (worst discomfort): Thinking about today, how would you rate the discomfort of your eyes?
Measured: Day 28
Global Discomfort Score
Change from D28 at Day 56
Measured: Day 56
Secondary outcomes (12)
Specific Blepharitis symptoms
Symptoms will be rated by the patient on the day of visit using 10-grade scales (0 = none to 10 = severe) for each of the following items Severity of any eyelid itching today / Severity of lid redness today / Severity of eyelid swelling today / How severe was the eyelid crusting this morning when you woke up? / How severe is missing lashes today?
Measured: Day 56
adapted Total Ocular Symptom Score (TOSS)
8-item questionnaire with an overall score ranging from 0 ("none of the time") to 4 ("all of the time"). It contains of a single question concerning the frequency with which 8 different symptoms (itchy eyelids, eyelid redness, red eyes generally, swollen (puffy) eyes, tearing (eyes watering), crusting around the lashes, burning or stinging sensations and noticed eyelash loss) were experienced in the course of a week.
Measured: Day 56
Symptom Assessment in Dry Eye (SANDE)
Comprised of two questions: 1) How often do your eyes feel dry and/or irritated? And 2) How severe you feel your symptoms of dryness and/or irritation are? This questionnaire uses a 100 mm horizontal line as visual analogue scale (VAS) for each question to assess ocular discomfort and/or dryness experienced by the patients. In the SANDE questionnaire, frequency of symptoms ranges from "rarely" to "all of the time" and the severity of symptoms ranges from "very mild" to "very severe".
Measured: Day 56
Demodex count
Sideways 'pull' on 10 eyelashes - upper or lower lashes Extent (mites present? yes or no) and Severity/Intensity (1=1 tail; 2=2 tails; 3 =2+tails)
Measured: Day 56
Ocular surface redness
Efron scale
Measured: Day 56
Lid margin redness/swelling
Efron/custom scale
Measured: Day 56
Cylindrical dandruff
Lash line coverage (%) and severity (mild/moderate/severe)
Measured: Day 56
Ocular surface staining
Oxford scale; corneal only
Measured: Day 56
Physician's impression and patient impression
Answer the item 'the treatment has been sufficiently effective' on a 4-point scale (strongly disagree, disagree, agree, strongly agree)
Measured: Day 56
Tolerability of the wipes
Tolerability assessment by the physician and patient (0 = intolerable; 1 = somewhat tolerable; 2 = tolerable; 3 = fully tolerable)
Measured: Day 56
Visual acuity
Snellen eye chart
Measured: Day 56
Assessment of ease of use
as experienced by the subjects, rated on a five-point scale of "Very Difficult" to "Very Easy".
Measured: Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start11 Sep 2019
- Primary completion13 Mar 2020
- Study completion14 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Demodex BlepharitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoires Thea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04780165
- Sponsor's protocol ID
- LTPIVBDX19
- Status last verified
- Mar 2021
- First submitted
- 23 Sep 2020
- Last updated
- 3 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Open Label, Multicenter Trial to Investigate the Efficacy and Tolerability of Blephademodex Wipes in Patients With Demodex Blepharitis
- ClinicalTrials.gov ID
- NCT04780165
- Acronym / sponsor ID
- LTPIVBDX19
- Conditions
- Demodex Blepharitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Laboratoires TheaIndustry (pharma, biotech, devices)
- Study start
- 11 Sep 2019 (actual)
- Primary completion
- 13 Mar 2020 (actual)
- Study completion
- 14 May 2020 (actual)
- First posted
- 3 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective
- To evaluate efficacy of Blephademodex eyelid hygiene wipe treatment with a subsequent maintenance period with Blephaclean lid cleansing wipes in Demodex blepharitis, as assessed by the change in ocular symptoms by a Global Discomfort Scale (GDS).
Secondary Objectives
- To evaluate the efficacy of Blephademodex eyelid hygiene wipe treatment in Demodex blepharitis as assessed by the change alone and in combination with a subsequent maintenance period of treatment with Blephaclean eyelid cleansing wipes ocular symptoms by: adapted TOSS; SANDE; specific blepharitis symptoms; Demodex count; ocular surface redness (Efron scale); lid margin redness/swelling (Efron / custom scale); Dandruff coverage at bases of eyelashes; ocular surface staining (Oxford scale; corneal only)
- To evaluate subject and physician satisfaction with Blephademodex eyelid hygiene wipes
- To evaluate ease of use for Blephademodex eyelid hygiene wipes
- Adverse events are documented and analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-arm | Experimental | Device: Blephademodex |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Patient > 18 years old, all genders
- Able to read, to write and to fully understand German language
- Good general health as determined by the investigator by medical history and physical appearance
- Provision of written informed consent prior to inclusion
- Moderate to Severe Blepharitis - grade ≥ 2 (Efron Scale)
Key exclusion criteria (7 listed)
- History of ocular trauma, ocular infection or intra-ocular inflammation within the 3 months before screening visit
- History of ocular refractive surgery and any other ocular surgeries within 3 months before screening visit
- History of ocular allergy or ocular herpes within the 3 months before screening visit
- History of inflammatory corneal ulcer within the 6 months before screening visit
- Sjogren syndrome or any other rheumatologic disease related dry eye
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BlephademodexAlso: BlephacleanDuring the first 28 days of the trial, subjects will use one Blephademodex® eyelid hygiene wipe every evening per eye to clean the eyelids of both their eyes. At the start of the second period the Investigator will assess based on the GDS if the condition is resolved and manage accordingly: subjects will either continue with this regime if GDS is unchanged (further treatment phase) or revert to Blephaclean wipes every evening instead (maintenance phase), again to clean the eyelids of both their eyes. | Device | Single-arm |
Primary outcome
Global Discomfort Score
Time frame: Day 28
Change from Baseline at Day 28 The Global (overall) discomfort score (GDS) consists of a single question, which can be answered by the subject by choosing a value between 0 (no discomfort) and 10 (worst discomfort): Thinking about today, how would you rate the discomfort of your eyes?
Global Discomfort Score
Time frame: Day 56
Change from D28 at Day 56
12 secondary outcomes
Specific Blepharitis symptoms
Time frame: Day 56
adapted Total Ocular Symptom Score (TOSS)
Time frame: Day 56
Symptom Assessment in Dry Eye (SANDE)
Time frame: Day 56
Demodex count
Time frame: Day 56
Ocular surface redness
Time frame: Day 56
Lid margin redness/swelling
Time frame: Day 56
Cylindrical dandruff
Time frame: Day 56
Ocular surface staining
Time frame: Day 56
Physician's impression and patient impression
Time frame: Day 56
Tolerability of the wipes
Time frame: Day 56
Visual acuity
Time frame: Day 56
Assessment of ease of use
Time frame: Day 56
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blephademodex in people with Demodex Blepharitis, run by Laboratoires Thea at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Discomfort Score (time frame: Day 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021.